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Asenapine has been approved by the FDA for the acute treatment of adults with schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults.[9] In Australia asenapine's approved (and also listed on the PBS) indications include the following:[10]

Schizophrenia

Treatment, for up to 6 months, of an episode of acute mania or mixed episodes associated with bipolar I disorder

Maintenance treatment, as monotherapy, of bipolar I disorder

In the European Union and the UK asenapine is only licensed for use as a treatment for acute mania in bipolar I disorder.[3][4]

Absorbed readily if administered sublingually, asenapine is poorly absorbed when swallowed.[11] It appears to less efficacious than other antipsychotics in the treatment of schizophrenia,[12] although its all-cause discontinuation rate is moderate.[12] As for its efficacy in the treatment of acute mania, a recent meta-analysis showed that it produces comparatively small improvements in manic symptoms in patients with acute mania and mixed episodes than most other antipsychotic drugs (with the exception of ziprasidone) such as risperidone and olanzapine. Drop-out rates (in clinical trials) were also unusually high with asenapine.[13] According to a post-hoc analysis of two 3-week clinical trials it may possess some antidepressant effects in patients with acute mania or mixed episodes.[14]